At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed NSCLC stage IIIB/IIIC or IV not amenable for curative treatment
- ✓PD-L1 ≥50% by validated method
- ✓Eligible for pembrolizumab monotherapy first-line setting
- ✓At least one non-irradiated measurable lesion by RECIST 1.1
- ✕Prior PD-1 or PD-L1 inhibitor treatment
- ✕Prior malignancy except non-melanoma skin cancer and specific in situ cancers unless complete remission ≥2 years prior
- ✕Known leptomeningeal carcinomatosis
- ✕Uncontrolled seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05344209Phase 2RecruitingUpdate OverdueUpdated 31mo ago · Completion was 12mo agoA Randomized Phase II, Open-label, Multicenter Study Investigating Efficacy and Safety of Pembrolizumab +/- UV1 Vaccination as First Line Treatment in Patients With Inoperable Advanced or Metastatic Non-small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating UV1, Sagramostim, and 1 other intervention for Oncology and 2 related conditions. Currently recruiting, targeting 138 participants across 1 site.
Signals
Detailed Summary
A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1/PD-L1-treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB/IIIC or stage IV NSCLC by treating with anti-PD-1/PD-L1 treatment and UV1 vaccination versus anti-PD-1/PD-L1 treatment alone.
Study Details
Timeline
Interventions
UV1 vaccine
for stimulation of local dendritic cell population to take up the vaccine and to mature into professional APCs
either pembrolizumab, atezolizumab or cemiplimab